Recruiting · registry status

Early testing of a substance used for medical imaging

Researchers study the safety of SST001, where it goes in the body and its radiation exposure in volunteers with and without movement conditions.

Testing a treatment or activity · Study reference: NCT07604116

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

Open the official registry record ↗

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Looking for volunteers

Start (reported actual date): 2026-06-15
Main measurements finished (planned): 2026-12
Study finished (planned): 2027-02

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded

2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.

Who can join?

Age 18 years and over · Also accepts healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

Inclusion Criteria: * Sign the informed consent form approved by IEC. * Male or female participants aged \>18 years old. * Adequate organ functions. * Proper contraception methods. * Willingness to follow the study procedures. * Additional inclusion criteria for healthy volunteers: Good health status; no history of motor disorders or cognitive disorders. * Additional inclusion criteria for MSA: Diagnosed with clinically established or clinically probable MSA according to the MDS MSA criteria (2022). If previously treated, the treatment regimen for MSA must have been stable for at least 4 weeks with no planned adjustments in the near term. * Additional inclusion criteria for PD: Diagnosed with clinically established or clinically probable PD according to the MDS PD criteria (2015). If previously treated, the treatment regimen for PD must have been stable for at least 4 weeks with no planned adjustments in the near term. Exclusion Criteria: * Being pregnant or lactating. * History of other severe neurological disorders. * History of serious or uncontrolled medical condition. * Active HBV/HCV/HIV infection, etc. * History of abuse of drugs or alcohol within 1 year. * Allergy to the study drug. * Intolerance to PET/CT or MRI (e.g. claustrophobia). * Any interventional clinical studies within 30 days. * Radiation exposure dose exceeding 50 mSv/year. * Prior therapy targeting α-Syn. * Other ineligible conditions for this study.

Full study name & original research details

Official study title

A Non-Randomized, Open-Label Phase I Study to Evaluate the Safety, Tolerability, Biodistribution, Radiation Dosimetry, and Pharmacokinetics of SST001 in Healthy Volunteers, Patients With Multiple System Atrophy, and Patients With Parkinson's Disease

Short title used by the registry

A Study to Evaluate Satety, Tolerability, Biodistribution, Radiation Dosimetry, and Pharmacokinetics of SST001 in Healthy Volunteers, Patients With PD and Patients With MSA

Original description

The non-randomized, open-label phase I study aims to evaluate the safety, tolerability, biodistribution, radiation dosimetry, and pharmacokinetics of SST001 in healthy volunteers, patients with MSA and patients with PD.

Further description from the registry

SST001 is a 18F-labeled PET tracer designed to detect alpha-synuclein (α-Syn) pathology in vivo, a hallmark of PD and MSA. The non-randomized, open-label phase I study aims to evaluate the safety, tolerability, biodistribution, radiation dosimetry, and pharmacokinetics of SST001 in healthy volunteers, patients with MSA and patients with PD.

Conditions reported: Multiple System Atrophy (MSA); Parkinson's Disease (PD)

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

ClinicalTrials.gov · NCT07604116 ↗ — RECRUITING; checked 2026-10-11

Study type: Interventional
Interventions: SST001
Phases: PHASE1
Sponsor: Synusight Biotech (Shanghai) Co., Ltd.
Start date reported by registry: 2026-06-15 (actual)

Registry updated: 2026-09-01 · Status last verified by the registry submitter: 2026-08

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Jian Wang, Professor · +86 021-52888163 · wangjian336@hotmail.com

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, China

Recruiting

Jing Chun Yu, Professor · +86 0510-68089401 · ycjwxd1978@jiangnan.edu.cn

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Recruiting

Jian Wang, Professor · +86 021-52888163 · wangjian336@hotmail.com

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.